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OPC Human Subjects
KYCOM Block 2
29
Law
Graduate
09/09/2012

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Cards

Term
what is the most legitimate human subject experimentation
Definition
medical
Term
what is the most dubious human subject experimentation
Definition
psychological
Term
what is the most dangerous human subject experimentation
Definition
biological
Term
describe benefience in regards to human experimentation
Definition
do not harm. maximize possible benifits, minimize possible harm
Term
what is justuce in regards to human experimentation (also give examples)
Definition
fairness in treatment (including haves and have nots), equality in distribution (randomization of placebos)
Term
what is an injustice when related to human subject experimentation
Definition
when a benefit entitled is denied without reason when some burden is imposed unduly
Term
when doing human subject experimentation wat is required
Definition
independent review, vaildity and value in research purpose and design, minimize risk, maxamize safety, fully inform each subect or authorized representitive, disclose any conflicts of interest, HIPAA authorization
Term
what is the fundimental principal in regards to human subject experimentation
Definition
independent review
Term
what is the definition of a human subject
Definition
living indivigual whom a research investigator obtains data through intervention or interaction with the individual or from individually identifiable information
Term
what is the definition of intervention
Definition
manipulation of the subject or the subject's enivornment
Term
what is the definition of private information and an example
Definition
interpersonal contact between investigator and subject (physical exam)
Term
what is the definition of identifiable information (give examples)
Definition
identity of the subject can be ascentained by the investigator or information associated with the subject (assigning a number, specific demographic)
Term
when are placebo controlls allowed
Definition
when scientifically or methodological reason, when study adresses a minor condition and the patient's recieving will not be subject to additional risk or irreversible harm
Term
how can you make sure your medical therapy human subject experimentation is in the best interest of the patient and all risks have been considered
Definition
appreach with peers, institutional review board, and other expert groups
Term
what does it mean when it is said that psychological research is more dubious
Definition
more often questioned
Term
what is the difference between medical and biological research
Definition
biological is more dangerous, medical is more ledegitamite and less invasive
Term
describe respect in regards to human subjects
Definition
subject must have the capacity to represent their own interest and free to say stop treatment, make sure not to exploit people, make sure people who are volurnable are protected, make sure subject is willing and there are no hidden contingencies (like prisoners have)
Term
what does it mean when said that human subject research must be valid and valuable
Definition
degree to which the research measures what it says it will, can be repeated with consistancy, able to be generalized for many populations, outcome improves treatment or prepares to improve it
Term
what are the types of human subject research
Definition
intervention, private information, identifiable information
Term
describe the Joseph Memgle studies
Definition
twin studies done by Nazis, injected blue dye to change eye color, forced male and female twins to reproduct, exchanged blood between twins, boiled bodies to preserve hunch back father and son
Term
describe the Tuskege research
Definition
men REPORTEDLY had LATENT syphillis, poor black men told they were being treated but ~200 were not treated at all, given meals and culturally sensitive mathods (funeral money) as incentives, NOT injected with syphillis,
Term
who put on the tuskege research and when
Definition
US public health in 1932
Term
why does the year the tuskege research started cause alarm
Definition
because a syphilis treatment was found in 1930 and was not offered to the subjects, it was kind of dangerous but worked
Term
what was the second point in time during the tuskege research that caused alarm
Definition
in 1943 penicillin was found to be a safer way to treat syphillis but they did not give the subjects the option to take it and gave them incentives not to
Term
who lead the fight against the tuskege research, describe the story how
Definition
Peter Buxton spoke with a subject and was concerned he was not getting penicillin, he wrote the CDC and they had a comittee meeting that said the research was once in a life time and must be continued, his GF wrote about it in the newspaper and another comittee viewed it as fine before penicillin but not ok now, congress made laws against bad research in result
Term
describe the harvard case
Definition
research was whistle blower and showed reliability and validity issues and altered data, it was moved from lower to circut cort and is still in trial
Term
what is a key point in regards to human research:
A. respect, harm, care
B. justice, humanity, truth
C. cecil, herbert, sinfield
D. respect, benifience, justice
Definition
D
Term
research should be reviewed by"
A. experts and the IRB
B. no one
C. only in limited circumstances
Definition
A
Term
what does the picture of soldiers represent:
A. troops exposed to TNT
B. radiation experiments
C. troops watching experiments
D. troops exposed to agent organge
Definition
B
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